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Emprint Ablation System
Summary: The Emprint Ablation System is a microwave ablation device used primarily for tumor ablation. It is FDA cleared and supported by clinical studies demonstrating its efficacy in creating predictable ablation zones.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K133821 ↗
Decision Date ?
April 28, 2014
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
11 studies
The Emprint Ablation System by Covidien was cleared through the FDA 510(k) pathway on April 28, 2014. It is classified as a Class 2 device under product code NEY.
What It Is
The Emprint Ablation System is a microwave ablation device designed to treat tumors by using electromagnetic waves to heat and destroy tissue. It is intended for use in patients with non-resectable tumors, providing a minimally invasive treatment option.
FDA-Cleared Indications
- Coagulation of soft tissue through the delivery of microwave energy.
- Use in percutaneous, laparoscopic, or surgical procedures when controlled thermal ablation of soft tissue is indicated.
- Use with compatible accessories and imaging guidance to create a planned zone of thermal tissue destruction.
Clinical Applications
- Image-guided microwave ablation of selected soft-tissue tumors.
- Percutaneous ablation procedures performed through a needle or applicator placed into the target tissue.
- Laparoscopic or open surgical microwave ablation when direct access to the target is required.
- Treatment of selected tumors when thermal ablation is chosen instead of, or as an alternative to, surgical resection.
Reported off-label uses
- Microwave ablation of uterine fibroids has been described in clinical practice and literature, but the specific use should be confirmed against the applicable labeling and institutional policy.
- Microwave ablation of selected benign or recurrent soft-tissue lesions has been reported, depending on anatomy, patient selection, and local regulatory requirements.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes a mix of prospective trials, reviews, and clinical studies, with a total of 9 studies ranging from 2015 to 2022. These studies evaluate the device's efficacy and safety in various tumor types.
Reported Outcomes
Published studies report that the Emprint Ablation System effectively creates large, predictable ablation zones, particularly in liver and lung tumors. The device has demonstrated high thermal efficiency and short ablation times, making it a viable option for patients with non-resectable tumors.
Safety Profile
Reported complications include the unpredictability of ablation zone size and shape in earlier generation devices, which the Emprint system aims to address. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the variability in study design and the lack of long-term outcome data. Further research is needed to establish standardized protocols and to evaluate the device's performance across different tissue types and clinical settings.
Practical Considerations
- The system includes microwave generators, ablation applicators, cables, and related accessories; available applicator dimensions and configurations depend on the specific product components.
- Applicator placement should be confirmed with an appropriate imaging modality, commonly ultrasound, computed tomography, or magnetic resonance imaging, according to the procedure and equipment configuration.
- The applicator and accessories should not be assumed to be MRI safe or MRI conditional; review the exact component labeling before performing a procedure in or near an MRI environment.
- Important risks include unintended thermal injury, bleeding, infection, damage to adjacent organs, incomplete treatment, and tumor recurrence.
- Contraindications and precautions depend on the target, access route, bleeding risk, infection status, implanted devices, and the instructions for use for the specific system and accessories.
Linked Studies (11)
PubMed • 2023
Emprint Microwave Thermoablation System: Bridging Thermal Ablation Efficacy between Human Patients and Porcine Models through Mathematical Correlation.
Bioengineering (Basel, Switzerland)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Comparative Study of Ablation Zone of EMPRINT HP Microwave Device with Contemporary 2.4 GHz Microwave Devices in an Ex Vivo Porcine Liver Model.
Diagnostics (Basel, Switzerland)
View Source →PubMed • 2021
New next-generation microwave thermosphere ablation for small hepatocellular carcinoma.
Clinical and molecular hepatology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
A review of conventional and newer generation microwave ablation systems for hepatocellular carcinoma.
Journal of medical ultrasonics (2001)
View Source →PubMed • 2019
New microwave ablation system for unresectable liver tumors that forms large, spherical ablation zones.
Journal of gastroenterology and hepatology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2018
A novel 3-dimensional electromagnetic guidance system increases intraoperative microwave antenna placement accuracy.
HPB : the official journal of the International Hepato Pancreato Biliary Association
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2017
Microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions : New advances in interventional oncology: state of the art.
Medical oncology (Northwood, London, England)
View Source →PubMed • 2016
A new system of microwave ablation at 2450 MHz: preliminary experience.
Updates in surgery
View Source →PubMed • 2015
The Emprint™ Ablation System with Thermosphere™ Technology: One of the Newer Next-Generation Microwave Ablation Technologies.
Seminars in interventional radiology
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
View Source →ClinicalTrials.gov
Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter
View Source →Frequently Asked Questions
What are the clinical indications for Emprint Ablation System?
The Emprint Ablation System is indicated for the treatment of non-resectable tumors, including liver and lung tumors, and uterine fibroids.
What outcomes have been reported in clinical studies?
Clinical studies report effective ablation with predictable zone sizes and high thermal efficiency, particularly in liver and lung tumors.
What complications have been reported?
Reported complications include issues with the predictability of ablation zone size and shape in earlier generation devices, which the Emprint system aims to improve.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.